- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07606898
Fractional Exhaled Nitric Oxide as Possible Non - Invasive Biomarker to Assess Obstructive Sleep Apnea Severity
Aim of work
- Primary aim: Asses correlation between FeNO level, OSA severity
- Secondary aim: Clarifying FeNO's role as a biomarker to assess airway inflammation, Cut off value prediction to moderate and severe OSA and its potential significance to improve clinical management strategies for OSA patients.
연구 개요
상태
상세 설명
Obstructive Sleep Apnea is a highly prevalent sleep-related breathing disorder characterized by recurrent episodes of upper airway obstruction during sleep, resulting in intermittent hypoxia, sleep fragmentation, and significant cardiometabolic consequences. The severity of OSA is traditionally assessed using overnight polysomnography (PSG), with the apnea-hypopnea index (AHI) serving as the gold standard metric. However, PSG is resource-intensive, time-consuming, and not readily accessible in many healthcare settings, particularly in resource-limited environments. This has driven increasing interest in identifying reliable, non-invasive biomarkers that could aid in the assessment of disease severity and reduce dependence on PSG.(1) Airway and systemic inflammation play a central role in the pathophysiology of OSA. Recurrent hypoxia-reoxygenation cycles induce oxidative stress and activate inflammatory pathways, leading to endothelial dysfunction and tissue injury.(1) Fractional exhaled nitric oxide (FeNO) is a well-established non-invasive biomarker of airway inflammation, widely used in the assessment of eosinophilic airway diseases such as asthma. Given its ability to reflect inflammatory processes within the respiratory tract, FeNO has been proposed as a potential marker in OSA.(2) Several studies have explored the relationship between FeNO levels and OSA. Some have demonstrated elevated FeNO levels in patients with OSA compared to healthy controls, along with positive correlations between FeNO and indices of disease severity such as AHI and oxygen desaturation index (ODI).(3) In contrast, other studies have reported inconsistent or weak associations, suggesting that the inflammatory profile in OSA (often predominantly neutrophilic rather than eosinophilic) may limit the specificity of FeNO as a biomarker in this context.
Importantly, the current literature is characterized by several limitations. Many studies have small sample sizes, heterogeneous populations, and inadequate control for confounding factors such as smoking, obesity, and coexisting airway diseases. Furthermore, most studies focus primarily on simple correlations with AHI, without evaluating the diagnostic performance of FeNO or its ability to discriminate between different severity categories of OSA. The absence of robust predictive models integrating FeNO with clinical parameters further limits its applicability in routine clinical practice.(4) Therefore, a significant gap remains regarding whether FeNO can serve as a clinically meaningful, non-invasive biomarker for stratifying OSA severity. In particular, there is a need for well-designed studies that not only assess the association between FeNO and polysomnographic parameters, but also evaluate its diagnostic accuracy and potential role within predictive models.
Accordingly, the present study aims to investigate the role of FeNO in assessing the severity of OSA, to determine its relationship with key polysomnographic indices, and to evaluate its potential utility as a non-invasive tool for disease stratification.
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Tanta, 이집트
- Tanta university
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
Study Type: prospective observational cross sectional study. Sample Size: This study will be carried out on 200 patients' suspected for obstructive sleep apnea, following approval of medical research ethical committee of Tanta University, Faculty of Medicine.
Sample size was calculated using this formula 2SD ^2 × (1.96 + 0.84)^2 /d^2 SD of FeNO 50 at moderate OSA 17.25 d is the difference between both means 21, 13.57 So at power of study 80% CI 95% Least Sample size will be 85 in each group
설명
Inclusion Criteria:
- Ages Eligible for study: 18 years till 70 years old.
- Newly suspected OSA patients with Epworth Sleepiness Scale (ESS) ≥ 10.
Exclusion Criteria:
- Current smokers.
- Any chronic Respiratory disorders other than OSA (asthma, COPD, allergic rhinitis, and atopic diseases).
- Younger age than 18 years.
- Recent inhaled or systemic corticosteroids within the pasr 4 weeks.
- Recent respiratory infection less than 4 weeks.
- Uncontrolled diabetes & any chronic debilitating diseases (liver, renal, collagen diseases) Informed Consent will be taken from the participants before clinical examination.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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• Control group AHI less than 5 \ hour - case groups Milld OSA & moderate to severe OSA
All 200 participants will undergo:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Asses correlation between FeNO level, OSA severity• through measuring FeNo level in 3 groups which will be divided according to AHI in PSG study -Control group AHI less than 5 \ hour, Mild OSA group AHI than 5-15 \ hour, Moderate to severe OSA group
기간: baseline
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address the correlation between PSG parameters performed by Somno medics screen including (apnea hypopnea index (event\ hour) oxygen nadir(%), oxygen desaturation index, % of time desaturation below 90% (T90), snoring index) and FeNo level ppb which measured by (Bedfont NIN006187 Nobreath) to Clarify FeNO's role as a biomarker to assess airway inflammation, and OSA severity, address FeNoCut off value as prediction tool to moderate and severe OSA and its potential significance to improve clinical management strategies for OSA patients. FeNo measurement precaution will be addressed as the participants will be asked to abstain from eating, drinking, and exercise, and avoid exposure to tobacco fumes 60 minutes before testing, so all cases FeNO assay will be hold at 9 am, Ask patients to refrain from Intake of nitrate-containing food like green-leaved vegetables on the day of assessment and then will be interprated according to ATS guidelines |
baseline
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Mohammed Sayed Hantira, professor, Tanta university
- 연구 의자: Ayman Hassan AbdElzaher, professor, Tanta university
- 연구 의자: Ahmed Gharib Gharib, assistant professor, cairo institute for research
- 연구 의자: Mohammed Samy Torky, assistant professor, Tanta university
- 수석 연구원: Martina Reda Abdo, lecturer, Tanta university
간행물 및 유용한 링크
일반 간행물
- Slowik JM, Sankari A, Collen JF. Obstructive Sleep Apnea. 2025 Mar 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459252/
- Ragnoli B, Radaeli A, Pochetti P, Kette S, Morjaria J, Malerba M. Fractional nitric oxide measurement in exhaled air (FeNO): perspectives in the management of respiratory diseases. Ther Adv Chronic Dis. 2023 Aug 1;14:20406223231190480. doi: 10.1177/20406223231190480. eCollection 2023.
- Zhu Q, Huang L, Zhu L, Zhang X, Ji H, Niu D, Ji W, Ma Q, Chen R, Shi H, Wang Y, Xu L. Association Between Fractional Exhaled Nitric Oxide (FeNO) and Cognitive Function in Patients with Obstructive Sleep Apnea. Nat Sci Sleep. 2025 Jul 12;17:1603-1614. doi: 10.2147/NSS.S524831. eCollection 2025.
- Michils A, Akset M, Haccuria A, Perez-Bogerd S, Malinovschi A, Van Muylem A. The Impact of Airway Obstruction on Feno Values in Asthma Patients. J Allergy Clin Immunol Pract. 2024 Jan;12(1):111-117. doi: 10.1016/j.jaip.2023.08.027. Epub 2023 Aug 25.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- FeNo in OSA
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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폐쇄성 수면 무호흡증(OSA)에 대한 임상 시험
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Fujian Shengdi Pharmaceutical Co., Ltd.모병Bstructive sleep apnea (OSA) 및 비만중국